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Course Name

OL-MDM-JMDM: Recorded Webinar - Japan New Regulations for Medical Devices Manufacturers

Slides

IMPORTANT: This is a recorded webinar.
Note: This course is free for BSI Internal Employees
The recorded version includes both Audio and the Web Conferencing Video.

Description

BSI’s “Japan – New Regulations for Medical Devices Manufacturers” webinar provides participants with the vital information they need to place products on the world's second-largest medical device market. This webinar is designed specifically for manufacturers exporting medical devices to Japan and provides an understanding of recent regulatory developments, including the revised Pharmaceutical Affairs Law (PAL) of 2002, which came into force on April 1, 2005.

Prerequisite

Students should have a basic understanding of medical device manufacturing before taking this course.

Topics Covered

  • Gain an Introduction to the Japanese Regulatory System for Medical Devices
  • Recognize the Requirements for Licenses of Medical Devices in Japan
  • Understand the Basics Quality Management Systems Requirements for Medical Device Manufacturers Exporting to Japan
  • Understand the Japanese Product Certification Requirements

    • Who Should Attend

  • Organizations who currently export medical devices to Japan or wish to expand into the Japanese market
  • Quality managers in the medical device industry

    • Course Timing

    This recorded version takes about 2 hours to complete.

    System Requirements

    An internet connection with at least Microsoft Internet Explorer 5 or Netscape 5. Also, Corporate Firewalls may prevent the dowload of the MP3 Audio file which can cause the course to hang. Only your IT department can determine if MP3's are being blocked.

    Certificate of Completion

    Please contact BSI (solutions.msamericas@bsi-global.com) to obtain a Certificate of Completion.
    A certificate will only be provided to each individual person who has purchased a seat for the recording.

    Description

    Note: BSI Japan is recognized by the Ministry of Health, Labor and Welfare (MHLW) in Japan under the revised PAL and, in conjunction with BSI Management Systems offices worldwide, is beginning certification services for medical device manufacturers placing their devices into the Japanese market. With this global approach, BSI helps manufacturer’s access global markets with the minimum necessary duplication of regulatory and quality assessment. In this critical transition period, it is important to stay informed of further regulatory developments in Japan.

    Slides

    Softcopy slides are available after registration by clicking on the Course Attachment icon in the Action column for the course.

     NOTE: E-Learning courses are typically available immediately upon enrollment.

    E-Learning
    Course DurationCourse Fee 
    0 DaysUSD $99.00Please log in to enroll.